Senior PKPD Programmer/Analyst Consultant -Onsite at Upper Gwynedd, PA at Clinchoice

Clinchoice

Upper Gwynedd, PA ·18h ago

SeniorFull-timeRust

Salary Range

$132,600 - $179,400 /year

Estimated

This salary is estimated based on similar roles. The actual salary may vary.

About the Role

We are seeking an experienced PK/PD Programmer to support pharmacokinetic and pharmacodynamic analyses across clinical development programs. This role is responsible for creating analysis datasets, generating tables/listings/figures (TLFs), and ensuring high-quality deliverables for regulatory submissions.

Key Responsibilities

→Develop and validate PK/PD analysis datasets (ADaM, SDTM as applicable)
→Generate Tables, Listings, and Figures (TLFs) for PK/PD studies
→Support population PK, exposure-response, and other modeling analyses
→Perform data cleaning and reconciliation between clinical and PK datasets
→Ensure compliance with CDISC standards (SDTM, ADaM)
→Support pharmacometricians in NONMEM, Monolix, or similar modeling platforms
→Prepare analysis-ready datasets for modeling
→Assist with model diagnostics, simulations, and reporting outputs
→Create graphical outputs for clinical study reports and regulatory submissions
→Perform QC and validation of programming outputs
→Support regulatory submissions (IND, NDA, BLA, etc.)
→Maintain documentation for programming activities
→Work closely with Clinical Pharmacology, Biostatistics, Data Management, and Medical Writing teams
→Participate in study team meetings and provide programming input
→Mentor junior programmers when needed

Requirements

✓5–8+ years of programming experience in clinical trials
✓3+ years of PK/PD programming experience
✓Experience with NMPKPD and ER datasets
✓Experience in Early-Stage Development studies
✓Experience with R programming preferred
✓Working knowledge of NONMEM, Monolix, Phoenix WinNonlin, or similar tools
✓Experience with CDISC standards (SDTM, ADaM)
✓Strong data manipulation and visualization skills
✓Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field